GSK's Arexvy becomes the first RSV vaccine approved for adults aged 50-59 who are at high risk.
GSK PLC (LSE:GSK, NYSE:GSK) has confirmed that the US Food & Drug Administration has approved Arexvy for preventing respiratory syncytial virus (RSV) in adults aged 50 to 59 at increased risk of severe outcomes from the cold-like infection. GSK estimates over 13 million US adults fall into this category.
The Food and Drug Administration expanded the approval of GSK's respiratory syncytial virus vaccine to adults ages 50 to 59 who are at increased risk of getting severely sick from the virus. The agency first approved GSK's jab in May 2023 for patients 60 and above, who are more vulnerable to severe cases of the virus.
The U.S. Food and Drug Administration approved the expanded use of GSK's respiratory syncytial virus vaccine on Friday in adults aged between 50 and 59, making it the first shot endorsed for that age group.
What was supposed to be a stellar day for GSK PLC (LSE:GSK, NYSE:GSK) at the annual American Society of Clinical Oncology turned into quite the opposite. News of an adverse ruling in a Delaware court affecting long-running litigation over Zantac, the heartburn tablet linked cancer, overshadowed what was a very bullish read-out from a trial of its Blenrep drug in people suffering multiple myeloma.
Many investors expected today's move in GlaxoSmithKline (NYSE: GSK ), with shares of GSK stock plunging more than 8% in early afternoon trading. That's because, on Friday, a Delaware judge ruled that expert witnesses would be allowed to testify in court that the company's discontinued Zantac heartburn medication may have caused cancer.
American depositary receipts (ADRs) of GSK Plc (GSK) tumbled in intraday trading Monday after a Delaware court ruled that lawsuits claiming the drugmaker's discontinued heartburn treatment, Zantac, causes cancer can go forward.
GSK shares decline more than 7% in pre-market trading on Monday in response to an unfavorable ruling by a state court in Delaware in the Zantac litigation.
GSK shares plunged Monday after the Delaware State Court ruled that expert witnesses can present scientific evidence in the roughly 75,000 cases relating to the discontinued heartburn drug Zantac. The drug was manufactured and sold by several companies from the 1980s until 2020, when it was recalled over concerns it contained a probable carcinogen called NDMA.
Deutsche Bank has maintained its "buy" rating on GSK PLC (LSE:GSK, NYSE:GSK) despite the recent setback in the Zantac litigation as it focused on the long-term potential of the stock. After hours on Friday, the Delaware Superior Court allowed over 70,000 lawsuits related to the heartburn drug to proceed, creating a significant overhang for the pharmaceutical giant.
GSK shares dropped 10% after a ruling by the Delaware State Court that will allow jury trials in cases brought by cancer sufferers who say the heartburn drug Zantac caused their condition. GSK said it's going to appeal the decision.
Shares in British drugmaker GSK dropped more than 9% on Monday after a Delaware judge allowed more than 70,000 lawsuits over discontinued heartburn drug Zantac to go forward.